Reengineering Methadone Treatment Study of Patient-centered Methadone Treatment

Reengineering Methadone Treatment: A Randomized Clinical Trial

The purpose of the study is to determine whether a change in the rules and staff roles in methadone treatment programs will result in greater lengths of stay in treatment and lower rates of heroin and cocaine use, crime and HIV-risk behavior as compared to methadone treatment as usual.

Study Overview

• Status: Completed
• Conditions: Opiate Dependence
• Intervention / Treatment: Other: Patient-Centered Methadone Treatment; Other: Methadone Treatment as usual

Detailed Description

Early drop-out and premature discharge from methadone treatment is common in the United States and may be associated with drug use and its associated problems. The purpose of this study is to evaluate the effectiveness of a novel approach to the organization methadone treatment in which the patient rules and staff roles of the clinic will be modified for study participants as compared to patients receiving standard methadone treatment.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21223
      • University of Maryland Drug Treatment Center
    • Baltimore, Maryland, United States, 21218
      • Institutes for Behavior Resources REACH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• opiate dependence
• newly admitted to methadone treatment

Exclusion Criteria:

• pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient-Centered Methadone Treatment; Patient-Centered Methadone Treatment alters the rules and staff roles in methadone treatment as usual in an attempt to increase treatment retention and improve patient outcomes.	Other: Patient-Centered Methadone Treatment; Unlike in treatment as usual, counseling will be encouraged but not required and counselors will be responsible for enforcing the clinic's rules. The rules will be enforced by the Clinical Director. Clinic rules will be modified such that involuntary discharge from treatment will be a rare event.
Active Comparator: Methadone Treatment as Usual; Methadone treatment provided as usual in the U.S.	Other: Methadone Treatment as usual; Counseling will be required and counselors will enforce the usual clinic rules. Involuntary discharge may occur for ongoing drug use or rule infractions as usually occurs in the clinic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Opiate Positive Urine Tests	Number of participants with opiate positive urine tests	12-months post-baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Cocaine Positive Urine Tests	Cocaine positive urine drug test	12-months post-baseline
Drug Use HIV Risk Behavior	HIV Drug Use Risk Assessment Battery Score ranges from 0 to 22. A higher score is considered to be associated with higher risk.	12-months post-baseline
Criminal Behavior	Days of criminal behavior	12-months post-baseline
Global Score on the World Health Organization Quality of Life Measure	Scale from 1 through 5. A higher score reflects a better quality of life.	12-months post-baseline
Number of Participants Meeting DSM-IV Opiate Dependence Criteria	Diagnostic and Statistical Manual (DSM)-IV criteria for opiate dependence	12-months post-baseline
Number of Participants Meeting DSM-IV Cocaine Dependence Criteria	Number of participants meeting DSM-IV cocaine dependence criteria	12-months post-baseline

Collaborators and Investigators

• Sponsor: Friends Research Institute, Inc.
• Investigators: Principal Investigator: Robert P Schwartz, M.D., Friends Research Institute, Inc.

Publications and helpful links

General Publications

• Mitchell SG, Monico LB, Lertch E, Kelly SM, Gryczynski J, Jaffe JH, O'Grady KE, Schwartz RP. Counseling Staff's Views of Patient-Centered Methadone Treatment: Changing Program Rules and Staff Roles. J Behav Health Serv Res. 2018 Jul;45(3):506-515. doi: 10.1007/s11414-018-9603-1.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: September 7, 2011
• First Submitted That Met QC Criteria: September 27, 2011
• First Posted (Estimate): September 28, 2011

Study Record Updates

• Last Update Posted (Actual): December 29, 2017
• Last Update Submitted That Met QC Criteria: December 5, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Methadone Treatment; Opiate dependence; Services research
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Respiratory System Agents; Antitussive Agents; Methadone
• Other Study ID Numbers: 2R01DA015842 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No